R. J. Reynolds Tobacco Company – FDA EIR, Aug 19, 2016

The FDA conducted a surveillance inspection of RJ Reynolds Tobaccoville Facility in Tobaccoville, NC, from August 16 to August 19, 2016. This inspection, carried out under the Federal Food, Drug and Cosmetic Act, as amended by the Tobacco Control Act, aimed to assess the firm's compliance with regulations governing tobacco products, including cigarettes and electronic nicotine delivery systems (ENDS) like Vuse. During the comprehensive review of operations, which included manufacturing, labeling, and distribution processes for both traditional cigarettes and ENDS products, investigators observed no objectionable conditions. Consequently, an FDA Form 483, Inspectional Observations, was not issued to the facility. Management was reminded of their ongoing responsibility for compliance with the pertinent regulatory framework. Discussions with the firm's leadership included clarification regarding product listings, import responsibilities, and the evolving regulatory landscape for tobacco products, particularly for ENDS. The company was encouraged to review their recall procedures to potentially include corrections for recalled products, though this was presented as a suggestion rather than a mandate due to the absence of observed violations. The firm is registered with the FDA and manufactures various cigarette brands and Vuse ENDS products, also acting as an importer and contract manufacturer for other brands.